[Federal Register: April 14, 2004 (Volume 69, Number 72)]
[Rules and Regulations]               
[Page 19765-19766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap04-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0278]

 
Prior Notice of Imported Food Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002; Joint Food and 
Drug Administration-Customs and Border Protection Plan for Increasing 
Integration and Assessing the Coordination of Prior Notice Timeframes; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Availability of joint plan.

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SUMMARY: The Food and Drug Administration (FDA) and Customs and Border 
Protection (CBP) announce the availability of a plan entitled ``Joint 
FDA-CBP Plan for Increasing Integration and Assessing the Coordination 
of Prior Notice Timeframes.'' The plan, which includes an assessment 
schedule, describes the process by which FDA and CBP intend to increase 
integration and examine whether we could amend the timeframe 
requirements in FDA's prior notice interim final rule (IFR) to have the 
same advanced notice timeframes for arrivals by land via road or rail, 
or arrival via air that are currently in CBP's advance electronic 
information rule.

DATES: Submit written or electronic comments by May 14, 2004.

ADDRESSES: Submit written requests for single copies of the plan to the 
Office of Regional Operations (HFC-100), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed 
adhesive label to assist that office in processing your request or 
include a fax number to which it may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the plan. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


FOR FURTHER INFORMATION CONTACT: Joseph McCallion, Division of Import 
Operations and Policy (HFC-170), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-6553.

SUPPLEMENTARY INFORMATION:

I. Background

A. FDA Prior Notice Interim Final Rule

    On October 10, 2003, FDA issued an IFR (the prior notice IFR) (68 
FR 58974) to implement new section 801(m) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), added by section 
307 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act), which required prior 
notification of imported food to begin on December 12, 2003. The prior 
notice IFR requires the submission to FDA of prior notice of food, 
including animal feed, that is imported or offered for import into the 
United States. The prior notice IFR requires that prior notice be 
submitted to FDA electronically via either CBP's Automated Broker 
Interface (ABI) of the Automated Commercial System (ACS) or the FDA 
Prior Notice System Interface (FDA PN System Interface) (21 CFR 1.280). 
Food imported or offered for import without adequate prior notice is 
subject to refusal and, if refused, must be held (21 CFR 1.283).
    Under section 801(m)(2)(A) of the FD&C Act, FDA is to choose 
timeframes that ``shall be no less than the minimum amount of time 
necessary for the Secretary [of Health and Human Services] to receive, 
review, and appropriately respond to such notification * * *.'' Using 
this standard, the prior notice IFR requires that the information must 
be submitted and confirmed electronically as facially complete by FDA 
for review no more than 5 days and no less than 8 hours (for food 
arriving by water), 4 hours (for food arriving by air or land/rail), 
and 2 hours (for food arriving by land/road) before the food arrives at 
the port of arrival (21 CFR 1.279). However, when we issued the prior 
notice IFR, FDA was committed to exploring ways to increase integration 
of advance electronic notification processes with CBP and reduce prior 
notice timeframes further. Indeed, we stated in the preamble of the 
prior notice IFR (68 FR 58974 at 58995) that, by March 12, 2004, FDA 
and CBP would publish a plan, including an implementation schedule, to 
achieve the goal of a uniform, integrated system, and to coordinate 
timeframes for import prior notice information while fulfilling the 
Bioterrorism Act mandates for air and truck modes of transportation 
with timeframes finalized by CBP when they finalize their rule entitled 
``Required Advance Electronic Presentation of Cargo Information'' (the 
Advance Electronic Information Rule).
    For this reason, as well as to obtain comments on other aspects of 
the prior notice rulemaking, we issued the IFR with an opportunity for 
public comment for 75 days. Moreover, to ensure that those who comment 
on the prior notice IFR would have had the benefit of our experience 
with the systems, timeframes, and data elements, FDA also stated that 
it intended to reopen the comment period for an additional 30 days in 
March 2004, coinciding with the issuance of the plan by FDA and CBP 
relating to timeframes.

B. CBP Advance Electronic Information Rule

    On December 5, 2003, CBP issued the Advance Electronic Information 
Rule (68 FR 68140), which requires CBP to receive, by way of a CBP-
approved electronic data interchange system, information pertaining to 
cargo before the cargo is either brought into or sent from the United 
States by any mode of commercial transportation (sea, air, rail, or 
truck). The cargo information required is that which is reasonably 
necessary to enable high-risk shipments to be identified for purposes 
of ensuring cargo safety and security and preventing smuggling under 
the laws enforced and administered by CBP. The Advance Electronic 
Information Rule implements the provisions of section 343(a) of the 
Trade Act of 2002, as amended by the Maritime Transportation Security 
Act of 2002.
    The relevant timeframes provided in the Advance Electronic 
Information Rule are as follows:
     For arrival by land via road at ports that are 
fully equipped to accommodate CBP's Advance Electronic Information 
Rule, no later than 1 hour prior to the arrival of the truck at the 
border, or for

[[Page 19766]]

Free and Secure Trade/Customs-Trade Partnership Against Terrorism 
(FAST/C-TPAT) participants, 30 minutes;
     For arrival by land via rail at ports that are 
fully equipped to accommodate CBP's Advance Electronic Information 
Rule, no later than 2 hours prior to the arrival of the train at the 
border;
     For arrival by air, no later than the departure 
time (``wheels up'') of the aircraft from any foreign port or place in 
North America, including locations in Mexico, Central America, South 
America (from north of the Equator only), the Caribbean, and Bermuda, 
and from other areas into ports that are fully equipped to accommodate 
CBP's Advance Electronic Information Rule no later than 4 hours prior 
to the arrival of the aircraft in the United States.

II. Joint FDA-CBP Plan for Increasing Integration and Assessing the 
Coordination of Prior Notice Timeframes

    After consultation, FDA and CBP have developed a plan to increase 
integration and assess whether FDA can adopt reduced timeframes. As set 
out in the plan, the agencies intend to assess whether FDA can meet its 
statutory mandate under section 801(m)(2)(A) of the FD&C Act if prior 
notice is received and confirmed electronically by FDA for review with 
reduced timeframes, including those adopted by CBP by mode of 
transportation listed in the following paragraphs, no fewer than:
     1 hour before arrival by land by road, or 30 
minutes for participants in FAST/C-TPAT;
     2 hours before arrival by land by rail;
     By ``wheels up'' for flights originating in 
North and Central America, South America (north of the Equator only), 
the Caribbean, and Bermuda; otherwise 4 hours before arrival by air.
    As noted previously, section 801(m)(2)(A) of the FD&C Act states 
that FDA shall by regulation prescribe the time of submission of the 
notification in advance of importation or the offering of the food for 
import, which period shall be no less than the minimum amount of time 
necessary for the Secretary to receive, review, and appropriately 
respond to such notification, and any timeframe FDA adopts in the final 
rule must be justified under this standard.

III. Comments

    Elsewhere in this issue of the Federal Register, we are reopening 
the comment period on the prior notice IFR. To be considered part of 
the rulemaking record, interested persons must submit to the Division 
of Dockets Management (see ADDRESSES) written or electronic comments on 
the plan as indicated in the DATES section of this document. Two copies 
of any mailed comments are to be submitted by commenting entities; 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
plan and comments FDA has received may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Interested persons who wish to submit general comments on the prior 
notice IFR should consult the document reopening the comment period 
that is published elsewhere in this issue of the Federal Register.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/bioterrorism/bioact.html.


    Dated: March 24, 2004.
Lester M. Crawford,
Acting Commissioner for Food and Drugs.

    Dated: April 6, 2004.
Robert C. Bonner,
Commissioner, Customs and Border Protection.
[FR Doc. 04-8515 Filed 4-9-04; 4:51 pm]

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